Devices and methods for blood flow assistance

Abstract

Devices and methods are disclosed for assisting in blood flow from a weakened or injured heart, particularly for pediatric patients. A low profile, multi-chambered implantable mechanism is used to collect blood from a blood vessel and re-pump the blood out with an induced pressure emanating from a fluid pressure source. The devices and methods described herein are easy to use and may be attachable to body tissue without use of suture anastomosis.

Description

BACKGROUND OF THE INVENTION[0001]1. Field of the Invention[0002]The present invention relates generally to blood flow assistance. More specifically, the present invention relates to devices and methods for extra-vascular blood flow assistance.[0003]2. Background of the Invention[0004]Maintaining proper blood flow is one of the basic tenets of promoting good health. The heart, being the primary organ responsible for the driving force of blood flow, has the heavy burden of incessantly pumping small volumes of blood in an endless loop within the circulatory system. Thus, it should be expected that any event that affects the proper functioning of the heart would, in turn, affect proper blood flow through the circulatory system, which, in turn, will affect body health. Such events that affect proper heart pumping function include, for example, congenital heart defects, accidents, and various types of surgery.[0005]For example, in one such event, cardiac surgery, the heart often is at lea...

AI Technical Summary

Benefits of technology

[0009]The present invention provides low-profile, implantable blood flow assistance devices or methods that include simple and versatile components, making it ready to use without significant training or preparation time. As used herein and throughout this disclosure, “low profile” means capable of being implanted within areas in the body with minimal interference with surrounding tissue because of the inherent shape of the device, designed to fit within such body areas.

[0010]Furthermore, a device or method according to the present invention includes components that readily attach to fluid pumping equipment currently in use in clinics, making it universally acceptable in most clinical environments. Particular exemplary devices include a blood chamber and a fluid chamber that are separated by a flexible membrane that extends into either chamber to affect the volume of blood or fluid. Also, an insertion end is included in particular embodiments that may use a variety of attachment components that simplify, strengthen and anchor the device with respect to body tissue.

Problems solved by technology

For example, low cardiac output syndrome following cardiac surgery is not uncommon, and may be caused by impaired cardiac performance due to left, right or biventricular failure.

Despite conventional pharmacologic treatment, some patients having had such procedures require the use of mechanical cardiac support to treat cardiac failure.

For children and infants, options are much more limited.

Application of the IABP for infants has a number of drawbacks, including limited hemodynamic effectiveness, difficulty in application, and limited availability.

Utilizing a pediatric VAD or extracorporeal life support (“ECLS”) may provide greater hemodynamic benefit than the pediatric IABP, but requires expensive equipment, specially trained personnel to deal with the complicated machinery, and has even more limited availability than the pediatric IABP.

The limited effectiveness, technical difficulty, complexity and expense associated with current technology result in suboptimal clinical success for many patients, particularly in pediatric cases.

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